STereotactic RadioAblation by Multimodal Imaging for VT (STRA-MI-VT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- SBRT efficacy based on reduction of VT episodes during 12 month follow-up
研究概览
简要总结
Study of multimodal-imaging guided stereotactic body radiotherapy (SBRT) for ventricular tachycardia (VT) ablation.
详细描述
STRA-MI-VT study is a spontaneous, open-label, not randomized, prospective clinical trial.
The objective of the study is to evaluate the safety and efficacy of SBRT in strictly selected patients with refractory VT.
Multimodal cardiac imaging combined with electroanatomic mapping to provide a specific patient's tailored SBRT treatment plan choosing amang different linear accelerators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking in this study.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICD/S-ICD recipients with refractory VT
- •Not eligible for conventional catheter ablation or -in alternative- that have undergone failing conventional catheter ablation attempts, refusing surgery for the treatment of the arrhythmia.
- •LVEF ≥ 20%.
- •Age ≥ 50 years.
- •Signed an IRB approved written informed consent document.
排除标准
- •Previous radiotherapy with cardiac involvement.
- •Pregnancy or breastfeeding.
- •Active myocardial ischemia.
- •Acute revascularation in the past 120 days.
- •Acute hemodynamic instability (cardiogenic shock/NYHA IV).
- •Serious disease with presumed life expectancy less than 12 months.
- •Any condition that is deemed a contraindication in the judgment of the investigators.
结局指标
主要结局
SBRT efficacy based on reduction of VT episodes during 12 month follow-up
时间窗: 12 months
There will be 6 week blanking period after therapy to allow for ablation effect
SBRT safety during 12 month follow-up
时间窗: 12 months
Serious adverse events will be defined using CTCAE v4.0 criteria.
次要结局
- Total mortality(12 months)
- Health related quality of life(12 months)
- Cardiac functional changes(12 months)
研究者
Corrado Carbucicchio
Head of Ventricular Intensive Care Unit
Centro Cardiologico Monzino